Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry

Coronary Artery Disease Clinical Trial

— BIGPICTURE  

Official title:

Physicians International CCTA Utilization Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932958
• Other study ID #: bigPICTURE
• Status: Completed
• Phase: N/A
• First received: July 5, 2009
• Last updated: December 8, 2012
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: MDDX LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This protocol describes an observational study whose goal is to collect de-identified Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from several hundred U.S. and international imaging facilities. The study uses an electronic data capture tool to collect de-identified CCTA utilization parameters and clinical findings in order to create a multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings. The registry will be used to determine areas of interest for future randomized controlled trials.

All data will be collected with patient identifiers removed and in complete accordance with HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk of patient confidentiality violations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants who are able and willing to consent for themselves

• Patients scheduled for CCTA examination

Exclusion Criteria:

• Patients who did not complete the planned CT imaging procedure due to mechanical error of the CT machine.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	MDDX	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
MDDX LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCTA utilization parameters and clinical findings		Two years	No
Secondary	90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies		Two years	No